An observational study in Hypernatremia, sponsored by Medical Centre Leeuwarden. Completed at 1 site in Netherlands. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-09-08.
Sponsored by Medical Centre Leeuwarden · Observational
This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients.
According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem, caused by sodium overload or water deficit. In spite of several interventions to reduce sodium intake and optimize fluid balance, critically ill patients still develop hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop a positive sodium balance. In animals sodium storage in the third compartment was found. Our hypothesis is that sodium storage in the third compartment is different in critically ill patients and this difference could play a role in the development of ICU-acquired hypernatremia.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's enrollment of 45 is below the median of 200 across 12 observational studies indexed under Hypernatremia.
Browse Hypernatremia studies →Medical Centre Leeuwarden is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients admitted to the ICU that fulfill the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation.
Procedure: Skin biopsies · Other: Blood and urine analysis · Other: Blood collection for RNA-investigation
Patients admitted to the ICU after coronary artery bypass grafting. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation.
Procedure: Skin biopsies · Other: Blood and urine analysis · Other: Blood collection for RNA-investigation
Patients that will undergo a hip replacement because of arthrosis. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation.
Procedure: Skin biopsies · Other: Blood and urine analysis · Other: Blood collection for RNA-investigation
2 3mm skin biopsies will be taken
Measurement of sodium, potassium and kidneyfunction in blood and urine.
A blood sample that, in case of relevant differences between groups, could be used for RNA-profiling.
Difference in sodium concentration in skin biopsy between groups
Skin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: outcomes of proteoglycans
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: binding capacity of proteoglycans
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: density of lymph capillaries
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: presence of macrophage influx
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: decorine - if enough tissue is available
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: versican (if enough tissue is available)
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is available
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available
Time frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Plan to share: Undecided — Depending on the requests of the magazine involved.
Ran from Nov 2016 to primary completion in Sep 2017, 10 months.
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Medical Centre Leeuwarden